Process Engineer – Technical Services (Equipment & Projects)

Asset Recruitment; Galway; On-site; EUR 50,000 - 75,000; Full time

Job summary

A leading recruitment agency seeks a Process Engineer for a global pharmaceutical company in Galway, Ireland. This 12-month contract role involves supporting equipment qualification and validation processes. Candidates should have substantial experience in validation and a relevant degree. The position requires knowledge of regulatory standards and involvement in maintaining the validated state of manufacturing equipment.

Qualifications

• 5–7 years in validation and technical services in sterile injectables.
• Experience with IQ/OQ/PQ for aseptic processing equipment.
• Strong understanding of regulatory guidelines.

Responsibilities

• Develop and review validation protocols for sterile manufacturing.
• Conduct risk assessments for validation strategies.
• Maintain validated condition of manufacturing equipment.

Skills

Validation expertise

Risk assessment

Knowledge of cGMP

Environmental monitoring

Education

Bachelor’s or Master’s degree in Engineering or Life Sciences

Job description

Process Engineer – Technical Services (Equipment & Projects)

About the opportunity

Join a global pharmaceutical company as a Process Engineer – Technical Services (Equipment & Projects).

This is a 12-month contract opportunity. In this role, you will be responsible for supporting the qualification and validation of manufacturing equipment, utilities, and systems, ensuring they remain in a validated state. You will collaborate with cross-functional teams, execute validation protocols, and support regulatory compliance, contributing directly to operational readiness and process excellence.

Responsibilities

• Develop, execute, and review Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for sterile manufacturing equipment.
• Conduct risk assessments (e.g., FMEA) to define validation strategies and critical parameters.
• Maintain the validated condition of manufacturing equipment, clean utilities, and process support systems.
• Qualify and validate aseptic filling lines, lyophilizers, autoclaves, depyrogenation tunnels, and isolator/RABS systems.
• Support qualification of clean utilities (e.g., WFI, clean steam, compressed air, HVAC).
• Ensure proper validation of automation and control systems (SCADA, PLC, MES) as required.
• Investigate validation deviations and non-conformances, implementing corrective and preventive actions (CAPAs).
• Evaluate the impact of equipment modifications and process changes on the validated state.
• Prepare and review validation documentation, including Validation Master Plans (VMP), protocols, and reports.
• Ensure compliance with Annex 1, ICH Q9 (Risk Management), ICH Q10 (Quality Systems), and FDA Process Validation Guidance.

Requirements

• Bachelor’s or Master’s degree in Engineering (Chemical, Mechanical, Biomedical, or related field) or Life Sciences.
• 5–7 years of experience in validation, equipment qualification, or technical services within a sterile injectables manufacturing.
• Expertise in IQ/OQ/PQ for aseptic processing equipment and utilities.
• Experience with validation lifecycle (URS, FAT/SAT, PQ) and computerized system validation (CSV).
• Strong understanding of cGMP, FDA, EMA, and Annex 1 guidelines.
• Knowledge of data integrity principles (ALCOA+).
• Practical experience with environmental monitoring systems and cleanroom qualification.
• Knowledge of autoclave and depyrogenation tunnel operation.
• Experience with load preparation, thermocouple calibration/placement, and handling biological indicators.

Preferred

• Familiarity with endotoxin spiking procedures.
• Lean Six Sigma or ASQ Certified Quality Engineer (CQE) certification.
• Knowledge of Process Analytical Technology (PAT) and digital validation tools.